Date: 2012-05-07
Type of information:
phase: 3
Announcement: results of interim analysis and termination of the trial due to a lack of clinically meaningful efficacy
Company: Roche (Switzerland)
Product: dalcetrapib
Action mechanism:
Disease:
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Trial details:
Latest
news: Roche has announced that following the results of the second interim analysis of the dalcetrapib dal-OUTCOMES Phase III trial, the independent Data and Safety Monitoring Board (DSMB) has recommended stopping the trial due to a lack of clinically meaningful efficacy. The dal-OUTCOMES trial evaluated the efficacy and safety profile of dalcetrapib when added to existing standard of care in patients with stable coronary heart disease (CHD) following an acute coronary syndrome (ACS). No safety signals relating to the dal-OUTCOMES trial were reported from the DSMB.
However the drug didn\'t provide benefit to the patients in the study. Roche has decided to terminate the dal-OUTCOMES trial and all the studies in the dal-HEART programme. This global development programme involvied six clinical trials: dal-OUTCOMES, dal-OUTCOMES 2, dal-PLAQUE 2, dal-ACUTE, dal-PLAQUE (completed) and dal-VESSEL (completed).
